As an authority on the development and commercialization of advanced medical technology, and having led thousands of new submissions, renewals, refilings, novated submissions for major multinationals worldwide, Dr. Kozikowski will share his perspectives in a presentation entitled “Strategic Management of the Global Market Clearance Portfolio.”

The presentation will address important innovative approaches and industry best practices, and will include:

How pursuing global market clearances as extemporaneous reactions to urgent business demands can put an RA organization on a “submission treadmill,” whereupon the organization never gets to the point where global market clearance opportunities are prioritized or planned;

How instead of operating in a reactive mode, one can manage global market clearance opportunities as a portfolio, wherein qualitative metrics of market clearance burden can be translated into quantitative metrics of opportunity value, and opportunities can be prioritized, ranked, forecasted, and funded – with accuracy; and

The framework for strategic management of the global market clearance portfolio, and an examination of some specific considerations of market clearance burden and valuation.

The Presentation Panel will include representatives from the European Union, the U.S. Department of Commerce, the U.S. Commercial Service, and Dr. Kozikowski.

The audience will include representatives from the U.S. FDA, regulatory affairs professionals, other business professionals and executives. The presentation will be held in conjunction with the 13th Annual FDA-Orange County Regulatory Affairs Educational Conference on June 17, 2010 at the Marriott Hotel, Irvine, CA.

Following the presentation, Dr. Kozikowski will be available for discussions and meetings to discuss the topics in greater depth.

Quotes & Commentary:

“It is an honor to have been invited to present, and I thank the OCRA leadership for their efforts in arranging this opportunity for international learning,” said clinivation Founder and CEO Joseph Kozikowski, M.D.

About OCRA:

The Orange County Regulatory Affairs Discussion Group (OCRA) is a nonprofit, volunteer organization composed of Regulatory Affairs professionals from the Southern California area interested in expanding their knowledge through educational programs and networking.

OCRA has over 700 members representing more than 225 companies in Orange County and surrounding areas. Our membership includes individuals who work in Life Sciences industries such as medical devices, pharmaceutical, biologics, IVD, dietary supplement, food, and cosmetics, to mention a few.

About clinivation

Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

Our cross‐functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.

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Customers

Clinivation solutions deliver the digital advantage to outperform in new business environments with innovative and better ways to succeed in global development and commercialization.

Our cross‐functional software brings people and knowledge to the point of action to eliminate revenue traps, overcome process complexity, and enable execution with full visibility, decision support, and controls.